BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2920056 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00198
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR GOT STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS USING A 1.75MM ROTABLATOR ROTALINK PLUS BURR TO ABLATE A PREVIOUSLY PLACED UNSPECIFIED STENT. MULTIPLE PASSES WERE MADE; THE BURR WAS ABLE TO ABLATE THE LESION BUT WAS UNABLE TO BE REMOVED. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO REMOVE THE BURR WITH NO SUCCESS. THE BURR WAS CUT AT THE ADVANCER AND A SNARE WAS USED TO REMOVE THE BURR WITH NO SUCCESS. THE PATIENT WAS SENT TO SURGERY AND HAD A BYPASS PERFORMED. TWO DAYS LATER, THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AND THE BURR WAS ABLE TO BE REMOVED USING A SNARE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25981 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention